February 26, 2010
By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.
“Under the Federal, Food, Drug, and Cosmetic Act, HIT software is a medical device.” That’s according to Dr. Jeff Shuren, the new director of the Device Center within FDA. Yikes. Dr. Shuren testified yesterday at a hearing of the HIT Policy Committee, Adoption/Certification Workgroup. The workgroup invited numerous speakers...